(52 days)
Invacare Model IRC 1001 Env
Not Found
No
The description details a standard compressor for nebulization, focusing on mechanical and electrical performance. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for use by patients requiring aerosolized medications, which directly relates to providing therapy. It supplies continuous positive pressure to a nebulizer, a device specifically used for drug delivery to treat respiratory conditions.
No
The device is described as a compressor designed to generate an aerosolized medicine for therapeutic purposes, not for diagnosing medical conditions.
No
The device description clearly states it is an "electrically powered piston type compressor" and provides physical dimensions and weight, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to supply air to a nebulizer for delivering aerosolized medications to patients. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description details a compressor that generates airflow. It does not involve analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- Lack of IVD Characteristics: There is no mention of reagents, assays, sample analysis, or any other activities typically associated with in vitro diagnostics.
This device is a medical device used for drug delivery, specifically for respiratory therapy.
N/A
Intended Use / Indications for Use
The Pulmo-Mist compressor is intended to be used to supply compressed air to a nebulizer to produce aerosolized medications as prescribed by a physician. The Pulmo-Mist compressor is designed for use by adult or pediatric patients requiring aerosolized medications.
The Pulmo-Mist Nebulizer Compressor is intended to be used to supply a continuous positive pressure to a nebulizer device for the purpose of generating an aerosol medicine.
Product codes (comma separated list FDA assigned to the subject device)
73 BTI, 73 CAF
Device Description
The Pulmo-Mist compressor is an electrically powered piston type compressor that provides approximately 6 I/min of air flow against a back pressure of 10 psig. It is designed to supply air to a small volume nebulizer. The package optionally contains a legally marketed small volume disposable nebulizer kit, specifically the Westmed "VIXONE®", manufactured by Westmed, Inc. and private labeled for distribution by Nidek Medical Products, in the original manufacturer's unopened package, Each such package includes a mouthpiece, a nebulizer, a connector tube and flexible air tubing and labeling. The nebulization particle size varies slightly depending on the nebulizer used and on the viscosity of the material being nebulized. When used with the VIXONE, the MMAD is approximately 1 µm with a saline solution. Other manufacturers of small volume nebulizers report similar values for similar flow rates.
The Pulmo-Mist compressor is a portable unit. It weighs approximately 3.2 pounds and has dimensions of 7.5 in w x 4.5 in h x 7.5 in d.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult or pediatric patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Pulmo-Mist compressor was tested in accordance with the electrical, mechanical and environmental performance requirements for home use respiratory devices described in the Anesthesiology and Respiratory Devices Branch's March 1992 document entitled "Reviewer Guidance for Home Use Respiratory Devices" and the November 1993 document entitled "Reviewer Guidance for Premarket Notification Submissions". The Pulmo-Mist compressor met all the required performance criteria and functioned as intended. Additionally, the Pulmo-Mist compressor was designed according to Underwriter's Laboratory (UL) UL544 Standard for Medical and Dental Equipment and UL 1431 Standard for Personal Hygiene and Healthcare Appliances. Summary results for the legally marketed device show equivalent performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Invacare Model IRC 1001 Env
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.6250 Portable air compressor.
(a)
Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
0
1300/ HADS
MAY 0 3 2002
H. 510(k) Summary
| Submitter: | Nidek Medical Products, Inc.
3949 Valley East Industrial Drive
Birmingham, AL 35217
Tel: 205-856-7200
Fax: 205-856-0533 |
| ------------ | ------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Contact Person: L. G. Suelter Tel: 205-856-7200 Ext 222 Email: Isuelter@nidekmedical.com
- Date Submitted: 31 December 2001
Trade Name of Device: Pulmo-Mist Compressor
Common Name: Nebulizer
Classification Name: Nebulizer (Direct Patient Interface) 21 CFR 868.5630
Equivalent Legally Marketed Device: Invacare Model IRC 1001 Env
Description: The Pulmo-Mist compressor is an electrically powered piston type compressor that provides approximately 6 I/min of air flow against a back pressure of 10 psig. It is designed to supply air to a small volume nebulizer. The package optionally contains a legally marketed small volume disposable nebulizer kit, specifically the Westmed "VIXONE®", manufactured by Westmed, Inc. and private labeled for distribution by Nidek Medical Products, in the original manufacturer's unopened package, Each such package includes a mouthpiece, a nebulizer, a connector tube and flexible air tubing and labeling. The nebulization particle size varies slightly depending on the nebulizer used and on the viscosity of the material being nebulized. When used with the VIXONE, the MMAD is approximately 1 µm with a saline solution. Other manufacturers of small volume nebulizers report similar values for similar flow rates.
The Pulmo-Mist compressor is a portable unit. It weighs approximately 3.2 pounds and has dimensions of 7.5 in w x 4.5 in h x 7.5 in d.
Image /page/0/Picture/12 description: The image shows the logo for NIDEK Medical. The word "NIDEK" is written in large, bold, black letters. Below the word "NIDEK" is the word "Medical" written in a smaller, cursive font. The word "Medical" is also black, but it is not as dark as the word "NIDEK".
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Intended Use: The intended use of the Pulmo-Mist compressor is to supply compressed air to a nebulizer to produce aerosolized medications as prescribed by a physician. The Pulmo-Mist compressor is designed for use by adult or pediatric patients requiring aerosolized medications.
Technological
Characteristics: The Pulmo-Mist compressor is technically equivalent to the referenced legally marketed device. Both devices comprise three basic components: a) an a.c. motor driven compressor which is from the same component supplier and the same model compressor, b) an ABS thermoplastic enclosure, and c) wiring, switch and interconnecting tubing. Both devices supply air to small volume nebulizers. The device contains no microprocessors or other electronic components that emit or are susceptible to electromagnetic interference.
Performance Data:
The Pulmo-Mist compressor was tested in accordance with the electrical, mechanical and environmental performance requirements for home use respiratory devices described in the Anesthesiology and Respiratory Devices Branch's March 1992 document entitled "Reviewer Guidance for Home Use Respiratory Devices" and the November 1993 document entitled "Reviewer Guidance for Premarket Notification Submissions". The Pulmo-Mist compressor met all the required performance criteria and functioned as intended. Additionally, the Pulmo-Mist compressor was designed according to Underwriter's Laboratory (UL) UL544 Standard for Medical and Dental Equipment and UL 1431 Standard for Personal Hygiene and Healthcare Appliances. Summary results for the legally marketed device show equivalent performance.
Conclusion:
Based on information contained in this 510(k) submission. Nidek Medical Products, Inc. concludes that the Pulmo-Mist compressor is substantially equivalent to the referenced legally marketed device.
Image /page/1/Picture/7 description: The image shows the logo for NIDEK Medical. The logo is in black and white, with the word "NIDEK" in large, bold letters. Below the word "NIDEK" is the word "Medical" in a smaller, cursive font. The logo is simple and professional, and it is likely used to represent a medical company.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with a swooping line above them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2002
Nidek Medical Products, Inc. c/o Pamela K. Gwynn Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle, NC 27709
Re: K020797
Pulmo-Mist Compressor Model #4323 Regulation Number: 868.6250, and 868.5630 Regulation Name: Portable Air Compressor, and Nebulizer Regulatory Class: II (two) Product Code: 73 BTI, and 73 CAF Dated: April 18, 2002 Received: April 22, 2002
Dear Ms. Gwynn:
This letter corrects our substantially equivalent letter of May 3, 2002 regarding the indications for use of your device. Our letter incorrectly limited your device to use in military environments.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your
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Page 2 - Ms. Pamela K. Gwynn
device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
510(k) Number K020747
Device Name:
Pulmo-Mist Nebulizer Compressor
Indications for Use:
The Pulmo-Mist Nebulizer Compressor is intended to be used to supply a continuous positive pressure to a nebulizer device for the purpose of generating an aerosol medicine.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Division of Cardiovascular & Respiratory Devices
510(k) Number K020797
Image /page/4/Picture/10 description: The image contains the logo for NIDEK Medical. The logo is in black and white, with the word "NIDEK" in large, bold letters. Below the word "NIDEK" is the word "Medical" in a smaller, cursive font. The logo is simple and professional, and it is likely used to represent the company on its products and marketing materials.